The Medical Devices (Amendment) Regulations 2003

Amendment of regulation 2 of the principal Regulations

2.  In regulation 2(1) of the principal Regulations (interpretation)—

(a) the words “, unless the context otherwise requires” are omitted;

(b) after the definition of “active implantable device”, there is inserted the following definition—

““animal” means any animal from a bovine, ovine or caprine species, as well as deer, elk, mink and cats;”;

(c) after the definition of “Directive 2001/83”, there is inserted the following definitions—

““Directive 2003/12” means Commission Directive 2003/12(1) of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC(2) concerning medical devices;

“Directive 2003/32” means Commission Directive 2003/32(3) of 23rd April 2003 on medical devices manufactured utilising tissues of animal origin;”;

(d) in the definition of “the Medical Devices Directives”, after “Directive 93/42” there is inserted “, read with Directive 2003/32”;

(e) after the definition of “national standard”, there is inserted the following definition—

““non-viable” means having no potential for metabolism or multiplication;”;

(f) in the definition of “notified body”, for “Part V of” there is substituted “Part V or”; and

(g) after the definition of “third country conformity assessment body”, there is inserted the following definition—

““tissue” means an organisation of cells and/or extra-cellular constituents;”.

(1)

OJ No. L 28, 4.2.2003, p.43.

(2)

OJ No. L 169, 12.7.1993, p.1; amended by Directive 98/79/EC (OJ No. L 331, 7.12.1998, p.1), Directive 2000/70/EC (OJ No. L 313, 13.12.2000, p.22) and Directive 2001/104/EC (OJ No. L 6, 10.1.2002, p.50).

(3)

OJ No. L 105, 26.4.2003, p.18.